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Trial registered on ANZCTR


Registration number
ACTRN12616000155493
Ethics application status
Approved
Date submitted
10/02/2015
Date registered
9/02/2016
Date last updated
21/12/2018
Date data sharing statement initially provided
21/12/2018
Date results information initially provided
21/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
effect of lung recruitment after cardiac surgery of morbidly obese patients.
Scientific title
Respiratory failure after cardiac surgery of morbidly obese patients: effect of lung recruitment maneuvers after weaning from mechanical ventilation in intensive care unit.
Secondary ID [1] 286146 0
P14-37815005
Secondary ID [2] 286147 0
ANSM (health authority) ID-RCB-2014-A01558-39
Universal Trial Number (UTN)
U1111-1167-1063
Trial acronym
MRRea
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute respiratory failure 296789 0
obesity 296790 0
cardiac surgery 296791 0
Condition category
Condition code
Surgery 297023 297023 0 0
Other surgery
Diet and Nutrition 297171 297171 0 0
Obesity
Cardiovascular 297766 297766 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lung atelectasis is frequently observed after open heart surgery. It may lead to hypoxemia, increased shunt fraction, and pulmonary complications in the postoperative period. Also during general anesthesia, as well as during the immediate postoperative period, obese patient are more likely than non obese patients to develop atelectasis.
After cardiac surgery, patients are transfered in intensive care unit. Patients are ventilated with volume controlled ventilation by MAQUET Servo i respirator which consisted of a tidal volume of 6-8 ml/kg and a positive end-expiratory pressure (PEEP) is applied at 5 cmH2O. PEEP is a pressure who is maintained within the airways during expiration at each expiratory cycle. It can be titrated from 0 to 20 cmH2O. This mechanical ventilation setting prevents the alveolar collapse formation at the end of expiration. The positive expiratory pressure also increases the time during which the gas exchange between alveolus and capillary occur. Sustainable maintenance of alveolar opening prevents the atelectasis formation.
Also, in cardiac surgery and morbidly obese patients, recruitment maneuvers improves oxygenation.
The main objective of the study is to evaluate the effect of maneuver recruitment and increasing PEEP on the incidence of respiratory distress after weaning from mechanical ventilation in obese patients after cardiac surgery.
We chose to carry out the recruitment maneuver using pressure controlled ventilation (i MAQUET Servo ventilator) with inspiratory pressure at 30 cmH2O and PEEP at 15 cmH2O during 4 minutes
In the hour following admission to intensive care, patients are randomized into 3 groups:
1/lack of recruitment maneuver and maintaining the initial ventilation (control group)
2/recruitment maneuver (RM) is applied with controlled pressure ventilation for 4 minutes then recovery to the initial ventilation. 5 cmH2O PEEP is continued during the mechanical ventilation with volume controlled ventilation after RM.
3/ recruitment maneuver is applied with controlled pressure ventilation for 4 minutes then recovery to the initial ventilation. 10 cmH2O is continued during the mechanical ventilation with volume controlled ventilation after RM.

recruitment maneuver is carried out immediatly after randomisation.
Intervention code [1] 291680 0
Treatment: Devices
Comparator / control treatment
no recruitment maneuver usual ventilation PEEP 5 (control group).
PEEP is a pressure administered as a continuous manner each exhalation cycle by MAQUET Servo i respirator. It is set at 5 cm H2O .
Control group
Active

Outcomes
Primary outcome [1] 294263 0
use of non- invasive ventilation at 48 hours post-extubation
Timepoint [1] 294263 0
at 48 hours post extubation.
Secondary outcome [1] 312895 0
the duration of mechanical ventilation is assessed by review of hospital records
Timepoint [1] 312895 0
discharge from intensive care
Secondary outcome [2] 313801 0
PaO2 / FiO2 ratio before and after the recruitment maneuver achievement during mechanical ventilation, and 6 and 12 hours postextubation. Every patient has a blood gas during mechanical ventilation and post extubation.
Timepoint [2] 313801 0
PaO2 / FiO2 ratio:
-before and after the recruitment maneuver achievement during mechanical ventilation
-6 hours postextubation
-12 hours postextubation
Secondary outcome [3] 313802 0
the occurrence of infectious pneumonia, diagnosed by bronchoalveolar lavage if presence of a new and persistant radiographic infiltrate accompanied with purulent secretions, fever> 38.3 degrees celsius, or leukocytosis count > 10^9/L
Timepoint [3] 313802 0
discharge from intensive care
Secondary outcome [4] 313803 0
the occurrence of atelectasis by radiography
Timepoint [4] 313803 0
the occurrence of atelectasis by radiography at 24 and 48 hours post surgery
Secondary outcome [5] 313804 0
the length of stay in ICU by review hospital records
Timepoint [5] 313804 0
duration of ICU stay
Secondary outcome [6] 314233 0
the occurrence of kidney failure as defined by the RIFLE's score:
creatinine levels multiplied by 2 and diuresis less than 0.5ml/kg/hours at 12 hours
Timepoint [6] 314233 0
discharge from intensive care

Eligibility
Key inclusion criteria
Morbidly obese patients with BMI>30 after cardiac surgery requiring mechanical ventilation in intensive care unit.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hemodynamic instability,
PAM < 40 mmHg or PAS 20% decrease during recruitment maneuver
oxygen saturation < 85% during recruitment maneuver

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6648 0
France
State/province [1] 6648 0
Le Plessis Robinson/Ile de France

Funding & Sponsors
Funding source category [1] 290719 0
Hospital
Name [1] 290719 0
Centre Chirurgical Marie Lannelongue
Address [1] 290719 0
133, avenue de la Resistance
92350 Le Plessis Robinson
Country [1] 290719 0
France
Primary sponsor type
Hospital
Name
Centre Chirurgical Marie Lannelongue
Address
133, avenue de la Resistance
92350 Le Plessis Robinson
Country
France
Secondary sponsor category [1] 289407 0
None
Name [1] 289407 0
Address [1] 289407 0
Country [1] 289407 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292357 0
Comite de protection des personnes
Ethics committee address [1] 292357 0
CHU Bicctre
78, rue du General Leclerc
94275 Le Kremlin Bicetre
Ethics committee country [1] 292357 0
France
Date submitted for ethics approval [1] 292357 0
16/10/2014
Approval date [1] 292357 0
10/12/2014
Ethics approval number [1] 292357 0

Summary
Brief summary
Obesity constantly increases in industrialized countries and is an independent risk factor for morbidity and mortality. After general anesthesia, particularly in patients with a BMI> 30, the occurrence of atelectasis, secondary to decreased lung compliance, vital capacity, increases the risk of acute respiratory failure (ARF).
After a cardiac surgery, using extracorporeal circulation, the use of mammary arteries, phrenic nerve injury, pain, tracheal aspirations are additional risk factors to the occurrence of atelectasis and hypoxemia.
The use of positive end-expiratory pressure (PEEP) and recruitment maneuvers (RM) during mechanical ventilation are different methods used routinely in anesthesia and intensive care unit to reverse the hypoxemia caused by atelectasis.
No randomized study has evaluated after cardiac surgery in patients with BMI > 30, the benefit of RM associated with PEEP on lowering occurrence of respiratory failure and the use of non- ventilation invasive, after weaning from mechanical ventilation.
The main objective of the study is to evaluate the effect of maneuver recruitment and increasing PEEP on the incidence of respiratory distress syndrome after weaning from mechanical ventilation in obese patients after cardiac surgery.


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54822 0
Dr Priscilla AMARU
Address 54822 0
Service de reanimation adulte (ICU)
Centre chirurgical Marie Lannelongue
133, avenue de la resistance
92350 Le Plessis Robinson
Country 54822 0
France
Phone 54822 0
+33 (0) 1 40 94 86 37
Fax 54822 0
+33(0) 1 40 94 25 61
Email 54822 0
p.amaru@ccml.fr
Contact person for public queries
Name 54823 0
Dr TRAORE AMINATA
Address 54823 0
Project Mnanager, PhD Clinical Research Unit Centre chirurgical Marie Lannelongue 133, avenue de la resistance 92350 Le Plessis Robinson
Country 54823 0
France
Phone 54823 0
+33 (0) 1 40 94 86 64
Fax 54823 0
+33(0) 1 40 94 25 61
Email 54823 0
a.traore@ccml.fr
Contact person for scientific queries
Name 54824 0
Dr Priscilla AMARU
Address 54824 0
intensive care physician MD
intensive care unit
Centre chirurgical Marie Lannelongue
133, avenue de la resistance
92350 Le Plessis Robinson
Country 54824 0
France
Phone 54824 0
+33 (0) 1 40 94 86 37
Fax 54824 0
+33(0) 1 40 94 25 61
Email 54824 0
p.amaru@ccml.fr

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary